A Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)
This study is ongoing, but not recruiting participants.
Sponsor:
Transcend Medical, Inc.
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01166659
First received: July 14, 2010
Last updated: July 3, 2012
Last verified: July 2012
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Purpose
This study is to evaluate the safety and effectiveness of CyPass implantation for lowering intraocular pressure in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy.
| Condition | Intervention |
|---|---|
|
Primary Open Angle Glaucoma (POAG) |
Device: CyPass 2FX Micro-Stent |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Comparative, Multicenter Clinical Study to Assess the Safety and Effectiveness of CyPass Implantation in Patients With Open Angle Glaucoma Refractory to Single or Multi-Agent Topical Therapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Transcend Medical, Inc.:
Primary Outcome Measures:
- Intraocular pressure (IOP) reduction [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Achievement of target intraocular pressure (IOP) with and without use of ocular hypotensive medication [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
- Ocular hypotensive medication use [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: CyPass 2FX Micro-stent |
Device: CyPass 2FX Micro-Stent
The CyPass 2FX Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front of the eye into the back of the eye. The CyPass 2FX has slightly different fixation and drainage design features than the CyPass 3FX.
Other Name: CyPass System 211
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of POAG
- Medicated IOP ≥ 21 and ≤ 35 mmHg
- Use of 1 - 4 topical IOP lowering medications
Exclusion Criteria:
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Use of oral hypotensive medication treatment for glaucoma
- Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
- Clinically significant ocular pathology other than POAG
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166659
Locations
| Austria | |
| University Eye Clinic | |
| Salzburg, Austria | |
| Bulgaria | |
| Specialized Hospital for Active Treatment of Ophthalmologic Diseases | |
| Sofia, Bulgaria | |
| Germany | |
| Schlosspark-Klinik, Department of Ophthalmology | |
| Berlin, Germany | |
| Augenklinik Cham | |
| Cham, Germany | |
| Klinik fur Augenheilkunde, Campus Lubeck | |
| Lubeck, Germany | |
| Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum | |
| Neubrandenburg, Germany | |
| Spain | |
| Institut Catala de Retina | |
| Barcelona, Spain | |
| San Carlos Clinical Hospital | |
| Madrid, Spain | |
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
| Study Chair: | Tsontcho (Sean) Ianchulev, MD, MPH | Transcend Medical, Inc. |
More Information
No publications provided
| Responsible Party: | Transcend Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01166659 History of Changes |
| Other Study ID Numbers: | TMI-10-03 |
| Study First Received: | July 14, 2010 |
| Last Updated: | July 3, 2012 |
| Health Authority: | Germany: Ethics Commission Austria: Ethikkommission Bulgaria: Ministry of Health |
Keywords provided by Transcend Medical, Inc.:
|
Glaucoma Glaucoma device Glaucoma surgery Intraocular pressure |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 16, 2013